Associate Director of Quality Assurance

Location – Berlin, Germany

About –

Scienta are teaming up with a outstanding Biotechnology company who are global market leaders and looking to develop their team with a new Associate Director of QA based in their Berlin office.

They are developing a deep pipeline of innovative RNAs based on their platform for diseases with a genetic basis. The depth and versatility of their technology gives the opportunity to address a wide range of conditions in virtually any therapeutic area.

The Associate Director, GMP Quality Assurance will support the development and execution of the QMS including Quality and Compliance activities during the product development life cycle processes and to ensure related practices adhere to market(s) Health Authority regulatory requirements as well as QMS expectations.

Role –

• Implement, maintain, and execute QMS + SOPs.
• Review & approve QMS documentation when required.
• Review production batch related documentation and execute technical release per requirements.
• Manage QA systems such as Change Control and CAPA.
• Perform GMP audit of service providers including Contract Manufacturers and Testing lab.
• Participate in development of GMP training program, on job documentation training for CMC personnel and provide on-going GMP training to CMC personnel.
• Support Quality Agreement development with GMP service providers as required by the CMC team.
• Develop audit plan and perform routine audits as per the internal audit program.
• Provide support during internal and external (HA) audits and ensure all corrective actions are addressed as per designated timelines.

Your Profile –

• Minimum 10 years of GMP Quality Assurance experience in the pharmaceutical, consumer health, or medical device industry.
• Strong attention to detail and documentation review skill set. Competent in training associates, innovate new systems, develop GMP culture for an organisation.
• Strong influencing and communication skills. Courage and resolve to do what’s right.
• Strong communication skills and fluent in English.
• QA and GMP experience in Pharmaceutical and regulatory requirements including auditing and inspection against regulatory / quality standards. Excellent analytical, organizational, and problem-solving skills.
• Demonstrated understanding best pharmaceutical industry practices, GMPs, and Quality Assurance and Regulatory.
• Team oriented individual with personal commitment to human relations, integrity, giving and receiving constructive feedback, adaptability, diversity, and communication.
• Proven ability to effectively prioritise workload and strong organisational skills.